Kornimate/medical-research-clean huggingface dataset:
kd6001 in combination with anti-pd-1 antibody±bevacizumab in patients with advanced hcc and other solid tumors

Conditions: Advanced HCC; Other Solid Tumors

Summary: this is a phase 1b/2, open label study to evaluate the safety, tolerability, pharmacokinetics and initial efficacy of kd6001 in combination with tislelizumab ± bevacizumab in patients with advanced hcc and other solid tumors.


Eligibility criteria:
main inclusion criteria: 1. being voluntary to sign the informed consent form. 2. male or female, aged ≥ 18 years. 3. patients whose estimated survival time is more than 3 months. 4. eastern cooperative oncology group (ecog) performance status score 0 or 1. 5. at least one measurable lesion is used as the target lesion according to the response evaluation criteria in solid tumors version 1.1(recist v1.1). 6. histologically or cytologically confirmed advanced solid tumors. have a current liver function meeting child pugh class a in patients with hcc. part a: advanced solid tumors. partb/c: hcc. 7. patients will agree to provide tumor tissue samples. 8. the results of laboratory examination during the screening period suggest that the subjects have good organ function. 9. male subjects with reproductive ability or female subjects with the possibility of pregnancy use effective contraceptive methods. 10. good compliance and follow-up. main exclusion criteria: 1. history of malignancy other than the disease under study within 5 years prior to screening，except those malignancies that are expected to be cured after treatment. 2. systematic treatment with antitumor drugs within 4 weeks prior to the start of this study. 3. prior treatment with anti-ctla-4 antibody. 4. adverse events caused by prior treatment did not recovered to nci-ctcae v5.0 grade 1 and below. 5. subjects with cns metastases or leptomeningeal disease. 6. subjects with an active, known or suspected autoimmune disease. 7. subjects with acute or chronic active hepatitis b or hepatitis c. 8. has histological or cytological diagnosis of fibrolamellar hcc, sarcomatoid hcc or mixed cholangiocarcinoma. 9. subjects suffers from severe cardiovascular and cerebrovascular diseases. history or evidence of bleeding diathesis or significant coagulopathy at risk of bleeding. 10. subjects with an active infection requiring systemic treatment. 11. known history of testing positive for human immunodeficiency virus (hiv). 12. subjects known to have active tuberculosis (tb). 13. pregnant or breastfeeding females. 14. known to be allergic to kd6001, tislelizumab, bevacizumab or its components.
examining mu opioid mechanisms of ketamine's rapid effects in ocd (mket2)

Conditions: Obsessive-Compulsive Disorder

Summary: the purpose of this study is to understand how ketamine works in the brain to bring about a reduction in ocd symptoms.

the proposed mechanistic trial would be the first to probe the role of ketamine's opioid properties in modulating fronto-striatal circuitry and bringing about reduction of ocd symptoms.

Eligibility criteria:
eligibility criteria for participants with ocd: inclusion criteria: * ages 18-65 * meet the criteria for ocd diagnosis * failed at least 1 prior trial of standard first-line ocd treatment * agree to the following lifestyle modifications: comply with requirements for fasting prior to the experimental session, not enroll in any other interventional clinical trials during the duration of the study, and commit to medication study procedures. * able to provide informed consent exclusion criteria: * prior naltrexone or ketamine use/exposure * any current or past medical/psychiatric condition that makes participation unsafe in the opinion of the investigator or study physician * pregnant or nursing, or able to become pregnant and are not practicing an effective means of birth control * the presence of metal in the body that is contraindicated for mri scans eligibility criteria for healthy volunteers: inclusion criteria: * ages 18-65 * able to provide informed consent exclusion criteria: * current or past use of psychotropic medication * pregnant or nursing females * the presence of metal in the body that is contraindicated for mri scans

Keywords: ocd ketamine naltrexone mri brain imaging ocd symptoms obsessive-compulsive disorder
effect of cosopt versus combigan on retinal vascular autoregulation in primary open angle glaucoma (poag)

Conditions: Glaucoma

Summary: we have completed a study in which we examined the response of the retinal circulation to changes in posture from sitting to lying down in patients with primary open angle glaucoma (poag). this alteration in position produces changes in the local blood pressure at the entrance to the retinal vasculature. in a healthy retina, the vasculature adapts by dilating and constricting in order to maintain a steady blood flow rate. in an eye with poag, this often does not occur. as a result, there are large fluctuations in blood flow which may produce the retinal neuronal damage associated with glaucoma. the purpose of this study is to demonstrate that topical anti-glaucoma treatments with agents that have vasoactive as well as iop-lowering effects can have a beneficial effect on maintaining a steady retinal blood flow rate even when there are changes in local blood pressure.


Eligibility criteria:
inclusion criteria: * poag * age 40 to 80 years * untreated iop greater than 21 mm hg exclusion criteria: * more than two iop lowering medications * exfoliation or pigment dispersion syndrome * diabetic retinopathy * history of ocular surgery

Keywords: retinal vascular autoregulation
a pilot trial to test the feasibility of utilizing home blood pressure monitoring to optimize the administration of midodrine among decompensated cirrhosis patients

Conditions: Cirrhosis, Liver; Portal Hypertension; Ascites Hepatic

Summary: this is a randomized single-blind feasibility trial to test the utilization of home blood pressure devices to improve the clinical management of decompensated cirrhosis patients.

this is a feasibility trial to determine the feasibility of using home monitoring devices (e.g. blood pressure cuffs) to improve outcomes for cirrhosis patients.

Eligibility criteria:
inclusion criteria: * patients will need to have decompensated cirrhosis defined as a child pugh score ≥ 7 exclusion criteria: * none
clearway™ rx registry trial

Conditions: Heart Diseases; Vascular Diseases

Summary: the primary goal of this registry is to collect data regarding the use of the clearway rx local therapeutic infusion catheter for all indications.

the registry will collect de-identified data regarding the indication for use, ease of use, drug perfusion, catheterization procedure details, success for intended use, and overall operator performance evaluation.

Eligibility criteria:
inclusion criteria: * subject required the use of the clearway rx local therapeutic infusion catheter. exclusion criteria: * subject not meeting the above inclusion criterion

Keywords: heart diseases. vascular diseases.
safety, efficacy and pharmacokinetics of ald403

Conditions: Migraine

Summary: the purpose of this study is to assess the safety, pharmacokinetics and efficacy of a single dose of ald403 in the prevention of migraine headache in frequent episodic migraineurs for 24 weeks.


Eligibility criteria:
inclusion criteria * diagnosis of migraine at ≤ 50 years of age (ichd-ii, 2004 section 1) * history of migraine ≥ 12 months with * ≥ 5 and ≤ 14 migraine days in each 28 day period in the 3 months prior to screening * use of acute migraine medications ≤ 14 days per 28 day period and, within those days, ≤ 10 days of triptan use per 28 day period in the 3 months prior to screening and the 28 day period of completion of ediary prior to randomization * women of child-bearing potential and males with partners of child-bearing potential must agree to use adequate contraception (oral or injectable \[depot\] estrogen, and/or progestogen, or selective estrogen receptor modulator contraceptive therapeutic, intrauterine contraceptive device, or double barrier method \[e.g., condom and diaphragm or spermicidal gel\]). non-childbearing potential is defined as post-menopausal for at least 1 year or surgical sterilization or hysterectomy at least 3 months before screening * any hormonal therapy (e.g., oral contraceptives, hormone replacement therapy) use is stable and ongoing for at least 3 months prior to screening and during the 28 day period from screening to randomization * agree not to post any personal medical data related to the trial or information related to the trial on any website or social media site (e.g., facebook, twitter) until the trial has been completed exclusion criteria * confounding pain syndromes including fibromyalgia, chronic musculoskeletal (e.g., low back pain), psychiatric conditions, dementia, or major neurological disorders other than migraine that interfere with the participation in the trial * diagnosis of complicated migraine, chronic tension-type headache, hypnic headache, hemicrania continua, new daily persistent headache, basilar, hemiplegic, or familial hemiplegic migraine * regular use (greater than 7 days) of prophylactic headache medication (any preventive medication or supplement with evidence of efficacy from at least 1 placebo-controlled trial) within 3 months, or onabotulinumtoxin a within 6 months prior to screening or during the 28 day period prior to randomization * cardiac surgery or cardiac symptoms within 3 months of screening and during the 28 day period prior to randomization * suspected or diagnosis of hypertension with or without antihypertensive treatment * any ongoing co-morbidity that in the opinion of the investigator will interfere with the participation in the trial * body mass index (bmi) \> 39 at screening * pregnant, breast-feeding, or planning to become pregnant during the trial * patients who have used opioids \> 5 days for the treatment of pain in more than 2 of the 6 months prior to screening or in the 28 day period prior to randomization

Keywords: migraine disorders phase 1 ald403
post market surveillance to evaluate the efficacy and safety of the indigo aspiration system in japan

Conditions: Acute Limb Ischemia; Arterial Occlusion Mesenteric Artery Superior; Acute DVT of Lower Extremity

Summary: this study aims to confirm the safety and effectiveness of the indigo aspiration system in patients requiring immediate treatment for acute lower extremity artery occlusion, acute superior mesenteric artery occlusion, or severe acute deep vein thrombosis. primary objective of the study is to collect predetermined data on use, safety and effectiveness, including clinical and technical performance of the indigo system in japan.


Eligibility criteria:
inclusion criteria: patients who meet appropriate use criteria per local japanese requirements for acute lower limb artery, acute upper mesentery artery occlusions, or severe acute deep vein thrombosis. exclusion criteria: patients who do not meet appropriate use criteria per local japanese requirements for acute lower limb artery, acute upper mesentery artery occlusions, or severe acute deep vein thrombosis.
sleep assessment: the benefits of identifying sleep disturbance using a sleep questionnaire

Conditions: Sleep Disturbance

Summary: the investigators are interested in measuring the influence of addressing sleep in the orthopedic setting. this includes assessing patient experience measures (satisfaction with the visit, perceived empathy, communication effectiveness) as well as greater engagement in their healthcare (patient activation). the investigators will also see what factors might be associated with sleep disturbance and if addressing sleep leads to an intervention such as cognitive behavioral therapy.

all adult (18+ years old) new patients seeing a musculoskeletal specialist will be invited to enroll. for the purposes of this trial, the investigators will include people with lesser degrees of sleep disturbance including anyone with a score greater than 3. for people that are enrolled in the trial, the researcher will record the psqi score and enter at the first page of survey filled out by the patient after meeting. p the patients in the intervention group will include those for whom their clinician was given their sleep questionnaire result before the visit. the control group will include patients whose clinicians do not view the results, simulating usual care. patients in both groups will fill out a survey entailing demographics, sleep quality, jspppe.

Eligibility criteria:
inclusion criteria: 1. adult patients (18+) 2. orthopedic new visit 3. sleep disturbance score \> 3 exclusion criteria: 1. inability to read. 2. diminished cognition preventing completion of the questionnaires.
combined pecs ii and transversus plane blocks versus erector spinae block in modified radical mastectomy

Conditions: Breast Cancer; Acute Postoperative Pain

Summary: the aim of this study is to compare the total morphine consumption in the first 24 hour postoperative between combined modified pectoralis block (pecs ii) and transversus plane block versus erector spinae block in modified radical mastectomy.

breast cancer is the most common malignancy in women in the united states and is second only to lung cancer as a cause of cancer death. breast surgery is commonly performed as a part of the management of breast cancer, is associated with considerable acute postoperative pain. ultrasound guided regional anesthesia is recommended to be a part of multimodal analgesia in order to manage the acute post-operative pain. new techniques are proposed to give adequate control of postoperative analgesia with less opioid needs in the first day postoperative. they include pectoralis nerve modified pectoralis, and erector spinae blocks. the investigators will compare modified pectoralis nerve block (pecs ii) plus transversus thoracic muscle plane (ttp) block versus erector spinae block on morphine consumption during first 24 h following modified radical mastectomy.

Eligibility criteria:
inclusion criteria: * age 18: 60 years old * asa (american society of anesthesiologists) physical status i ii * female patients scheduled for modified radical mastectomy exclusion criteria: * patient refusal or inability to give informed consent * subjects with a medical contraindication to regional anesthesia , such as coagulopathy, local infection or an allergy to local anesthetic * body mass index (bmi) \>35 * presence of psychiatric diseases * history of chronic chest wall pain or neuropathic disorders * alcohol or drug abuse * severe chest wall deformities

Keywords: breast cancer regional anaesthesia morphine consumption
efficacy and safety of two doses of liarozole vs. placebo for the treatment of lamellar ichthyosis

Conditions: Ichthyosis, Lamellar

Summary: lamellar ichthyosis is a congenital disease of the skin with a generalized scaling. the primary activity of liarozole is considered to be the inhibition of the degradation of a substance called retinoic acid, which is the principal endogenous regulator of growth and differentiation of epithelial tissues in mammals. the current study intends to evaluate the efficacy and safety in patients with lamellar ichthyosis.

lamellar ichthyosis is an autosomal recessive disorder that is apparent at birth and is present throughout life. although the disorder is not life threatening, it is quite disfiguring and causes considerable psychological stress to affected patients. prevalence is less than 1 case per 300,000 individuals. treatment is mainly symptomatic i.e. emollients with or without keratolytic agents. treatment with systemic retinoids is reserved for those patients, refractory to conventional therapy, because of the long-term adverse effects and teratogenicity of systemic retinoids. liarozole may provide a new concept for the treatment of this condition. because of its mechanism of action, retinoic acid (ra) levels will only be increased in tissues that are targets for ra production. the proposed phase ii/iii study intends to evaluate the efficacy of liarozole compared with placebo, in patients with lamellar ichthyosis.

Eligibility criteria:
inclusion criteria: * subjects of either sex aged 14 years or older. * clinical diagnosis of lamellar ichthyosis * women of childbearing potential should use appropriate contraception * women of childbearing potential should have a negative pregnancy test at screening visit. * subjects are, except for their lamellar ichthyosis, in good general health. * subjects and legal representative(s), if applicable, signed informed consent. exclusion criteria: * subject is receiving topical (except emollient), uv treatment or systemic treatment for ichthyosis. * subject is pregnant or breast feeding. * history or suspicion of alcohol or drug abuse. * significant co-existing diseases. * clinically significant abnormal ecg * history of hypersensitivity to retinoids or any of the ingredients in the trial medication. * clinically relevant laboratory abnormalities at screening. * use of immune-suppressive drugs including topical or systemic corticosteroids. * participation in an investigational trial 30 days prior to the start of the trial.

Keywords: lamellar ichthyosis liarozole investigator's global assessment scaling
comparing between co2 and phenylephrine treatment in patients with progressive lacunar infarction (carbogen study)

Conditions: Acute Ischemic Stroke

Summary: lacunar infarction is an ischemic stroke occurred by small perforating artery occlusion . twenty percent of ischemic stroke is lacunar infarction. however, outcome of lacunar infarction is excellent, about 20-40% patients are suffered neurological worsening. progressive lacunar infarction is associated poor functional outcome and neurological deficit. currently, no treatment for progressive lacunar infarction is recommended on the guideline. several small study reported that phenylephrine and magnesium may be helpful for progressive lacunar infarction. carbogen is a mixture of 5% co2 with 95% o2. carbogen is safe and it is used for the treatment of sudden sensory neural hearing loss or ocular ischemia. co2 dilate cerebral arteriole and concentration of co2 is correlated with cerebral blood flow. lacunar infarction is small and perfused with marginal flow by neighboring perforating arteriole. increased cerebral blood flow following dilation of cerebral arteriole by co2 might halt and revert progressive lacunar infarction. induced hypertension is alternative treatment of progressive lacunar infarction. increasing blood pressure also induce cerebral blood flow. phenylephrine is an α1 agonist, phenylephrine act on peripheral artery and little effect on cerebral artery or heart. several studies reported that the effectiveness of phenylephrine on progressing stroke. therefore, this study will compare the effectiveness of carbogen versus phenylephrine in lacunar infarction patients who suffered neurological worsening.


Eligibility criteria:
inclusion criteria: 1. age ≥20 years 2. anterior circulation progressive lacunar infarction. 3. neurological worsening either 1 point in nihss score or mrc grade exclusion criteria: 1. age \<20 2. cortical infarction 3. posterior circulation lacunar infarction 4. relevant artery stenosis more than 50% or occlusion 5. moyamoya disease 6. difficulty in inhalation of carbogen (panic, severe anxiety disorder) 7. drug allergy for phenylephrine 8. persistent bradycardia (pulse rate \< 50 /min) 9. history of hemorrhagic stroke 10. pre-stroke mrs ≥2

Keywords: co2 carbogen phenylephrine lacunar infarction progressive stroke
tamoxifen in treating patients with primary liver cancer

Conditions: Liver Cancer

Summary: rationale: estrogen can stimulate the growth of cancer cells. hormone therapy using tamoxifen may fight liver cancer by blocking the absorption of estrogen. it is not yet known whether receiving tamoxifen is more effective than no further therapy in treating patients with primary liver cancer. purpose: randomized phase iii trial to compare high-dose tamoxifen with no further treatment in treating patients with liver cancer that cannot be surgically removed.

objectives: i. assess the therapeutic role of tamoxifen in patients with inoperable hepatocellular carcinoma in terms of overall survival and quality of life. outline: this is a randomized, double blind, placebo controlled study of tamoxifen. patients are randomized to one of 3 treatment arms. arm i: patients receive placebo orally twice daily for one year. arms ii and iii: patients receive tamoxifen, at 1 of 2 different doses, orally twice daily for one year. quality of life is assessed before treatment and then monthly thereafter. patients are followed monthly until death. projected accrual: this study will accrue 300 patients.

Eligibility criteria:
disease characteristics: histologically or radiologically confirmed inoperable hepatocellular carcinoma serum alfa-feto protein level at least 500 ug/l or positive lipiodol uptake patient characteristics: age: 10 to 90 performance status: ecog 0-3 life expectancy: not specified hematopoietic: not specified hepatic: not specified renal: creatinine less than 1.7 mg/dl other: no encephalopathy prior concurrent therapy: biologic therapy: not specified chemotherapy: no prior chemoembolization therapy for disease no prior systemic chemotherapy for disease endocrine therapy: not specified radiotherapy: not specified surgery: no prior surgery for disease other: no prior percutaneous injection

Keywords: localized unresectable adult primary liver cancer advanced adult primary liver cancer adult primary hepatocellular carcinoma
epat: estrogen in the prevention of atherosclerosis trial

Conditions: Atherosclerosis; Postmenopause

Summary: the purpose of this study is to determine the effects of estrogen replacement therapy (ert) on the progression of early atherosclerosis in healthy postmenopausal women without preexisting cardiovascular disease (cvd).

the primary goal of this randomized, controlled trial is to determine if ert stabilizes, retards, and/or reverses the progression of atherosclerosis in postmenopausal women. we will further evaluate the association of lipid and non-lipid factors of ert-mediated reduction in the progression of early atherosclerosis. ultrasonography will be used to measure the rate of change in the thickness of the carotid artery. blood samples will be used for measuring lipid and non-lipid mediators of ert. a total of 222 healthy postmenopausal women 46 to 80 years old without cvd symptoms will be randomized to receive either micronized 17b-estradiol (estrace) 1mg/day, or a matching placebo tablet daily. all women will be on a low fat/low cholesterol diet, and will receive pravastatin if their ldl cholesterol level exceeds 160 mg/dl. participants will undergo ultrasonography at baseline and every 6 months throughout the 2 years of randomized treatment. measurements of lipid and non-lipid biochemical markers will also be done at baseline and every 6 months.

Eligibility criteria:
inclusion criteria: * postmenopausal female (serum estradiol less than 20 pg/ml) * 46 to 80 years old * fasting ldl-c levels 130 to 210 mg/dl * triglyceride levels less than 400 mg/dl * current non-smoker exclusion criteria: * clinical evidence of cardiovascular disease * hdl-c level less than 30 mg/dl * fasting blood glucose greater than 200 mg/dl * previous hormonal replacement therapy (non-contraceptive) over 10 years duration and/or current use within 1 month * uncontrolled hypertension * untreated thyroid disease * renal insufficiency * clinical evidence of congestive heart failure * life threatening disease with prognosis less than 5 years * alcohol intake greater than 5 drinks per day (1 drink = 1 1/2 oz distilled spirits, 4 oz wine, or 12 oz beer) or substance abuse (intravenous drug abuse, cocaine use) * history of estrogen dependent cancer or detected at screening or any other disorder precluding use of ert * hot flashes greater than 5 per day which interfere with daily activity and preclude randomization to placebo.

Keywords: cardiovascular disease cvd estrogen cholesterol ldl lipids postmenopausal